Clomicalm
Clomipramine
Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC
1ère avenue – 2065 m – LID 06516 Carros
France
Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
Clomipramine hydrochloride
5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride(equivalent to 71.7 mg Clomipramine)
5 mg tablet: Brownish-grey, oval-oblong, divisible. Scored on both sides.
20 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears the imprint ‘C/G’, the other ‘G/N’ and scored on both sides.
80 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears the imprint ‘I/I’, the other no imprint and scored on both sides.
As an aid in the treatment of separation related disorders manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants. Do not use in male breeding dogs.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued. Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system. Vomiting may be reduced by co-administration with a small quantity of food.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated )
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated )
very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Dog
Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2-4 mg/kg according to the following table:
Body weight | Clomicalm 5 mg | Clomicalm 20 mg | Clomicalm 80 mg |
1.25 - 2.5 kg | ½ tablet | --- | --- |
>2.5 - 5 kg | 1 tablet | --- | --- |
>5 - 10 kg | --- | ½ tablet | --- |
>10 - 20 kg | --- | 1 tablet | --- |
>20 - 40 kg | --- | --- | ½ tablet |
>40 - 80 kg | --- | --- | 1 tablet |
Clomicalm may be given orally with or without food.
In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders. Some cases may require longer treatment. In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
Not applicable
Store in the original container. Keep out of sight and reach of children as accidental ingestion should be regarded as serious.
Do not use after the expiry date which is stated on the label after EXP.
Special warnings for each target species It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio. Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention. Clomicalm should be used under veterinary supervision. The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In children, accidental ingestion should be regarded as serious. There is no specific antidote. In case of accidental ingestion, seek medical advice immediately and show the product label to the physician. Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected. People with known hypersensitivity to clomipramine should administer the product with caution.
Any unused veterinary medicinal product or waste materials derived form such veterinary medicinal products should be disposed of in accordance with local requirements.
For animal treatment only.
Pack size: 30 tablets
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
VIRBAC BELGIUM NV
Esperantolaan 4 BE-3001 Leuven
Tél/Tel : +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Prancūzija
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Франция
Teл: +33-(0)4 92 08 73 00
VIRBAC BELGIUM NV
Esperantolaan 4 BE-3001 Leuven Belgique / Belgien
Tél/Tel: +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francie
Tel: +33-(0)4 92 08 73 00
VIRBAC HUNGARY KFT
Szent Istvàn krt.11.II/21. HU-1055 Budapest
Tel: +36703387177
VIRBAC Danmark A/S
Profilvej 1
DK-6000 Kolding Tlf: +45 75521244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Franza
Tel: + 33-(0)4 92 08 73 00
VIRBAC Tierarzneimittel GmbH Rögen 20
DE-23843 Bad Oldesloe Tel: +49-(4531) 805 111
VIRBAC Nederland BV Hermesweg 15
NL-3771 ND-Barneveld Tel : +31-(0)342 427 127
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Prantsusmaa
Tel: +33-(0)4 92 08 73 00
VIRBAC Danmark A/S Profilvej 1
DK-6000 Kolding
Danmark
Tel: + 45 75521244
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση
Τηλ: +30 2106219520
VIRBAC Österreich GmbH
Hildebrandgasse 27 A-1180 Wien
Tel: +43-(0)1 21 834 260
VIRBAC ESPAÑA SA
Angel Guimerá 179-181
ES-08950 Esplugues de Llobregat (Barcelona)
Tel. : + 34-(0)93 470 79 40
VIRBAC Sp. z o.o.
ul. Puławska 314
PL 02-819 Warszawa
Tel.: + 48 22 855 40 46
France VIRBAC France 13e rue LID
FR-06517 Carros
Tél : +33-(0)805 05 55 55
VIRBAC de Portugal Laboratórios LDA R.do Centro Empresarial
Ed13-Piso 1- Esc.3 Quinta da Beloura PT-2710-693 Sintra
Tel: + 351 219 245 020
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francuska
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Franţa
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros
France
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francija
Tel : + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Frakkland
Sími: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francúzsko
Tel: + 33-(0)4 92 08 73 00
VIRBAC SRL
Via Ettore Bugatti, 15 IT-20142 Milano
Tel: + 39 02 40 92 47 1
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Puh/Tel : + 33-(0)4 92 08 73 00
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση
Τηλ.: +30 2106219520
VIRBAC Danmark A/S Filial Sverige
SE-171 21 Solna
Tel: +45 75521244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francjia
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros France
Tel: + 33-(0)4 92 08 73 00